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Platinum-based Chemotherapy
Chemotherapy +/− Ramucirumab for Thymic Cancer
Phase 2
Waitlist Available
Led By Anne S Tsao
Research Sponsored by SWOG Cancer Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have unresectable thymic carcinoma, that is either locally advanced, recurrent, or metastatic
Patients must have a Zubrod performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests how well carboplatin and paclitaxel work with or without ramucirumab to treat patients with thymic cancer that has spread or returned.
Who is the study for?
This trial is for adults with advanced, recurrent, or metastatic thymic cancer that can't be surgically removed. They should not have had previous systemic anti-cancer therapy for this condition and must have measurable disease. Participants need proper liver and kidney function, no significant blood clots or bleeding in recent months, controlled blood pressure, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study compares the effectiveness of chemotherapy drugs carboplatin and paclitaxel alone versus combined with ramucirumab (a monoclonal antibody) in treating thymic cancer. The goal is to see if adding ramucirumab improves treatment outcomes compared to just chemotherapy.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, increased risk of infection due to lowered white blood cell counts, nausea, fatigue from chemotherapy agents like carboplatin and paclitaxel; ramucirumab may cause high blood pressure, bleeding problems including gastrointestinal bleeds or wound healing complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My thymic carcinoma cannot be removed by surgery and has spread.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I cannot have surgery to remove my cancer.
Select...
I have not received any systemic anti-cancer treatments for my advanced thymic carcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Disease control rate (complete response, partial response, confirmed or unconfirmed, stable disease)
Incidence of adverse events
Overall survival
+1 moreSide effects data
From 2016 Phase 3 trial • 1253 Patients • NCT0116897346%
Fatigue
36%
Neutropenia
32%
Diarrhoea
30%
Decreased appetite
27%
Nausea
26%
Alopecia
24%
Dyspnoea
23%
Stomatitis
22%
Cough
22%
Anaemia
19%
Epistaxis
18%
Neutrophil count decreased
17%
Oedema peripheral
17%
Constipation
16%
Mucosal inflammation
16%
Pyrexia
14%
Lacrimation increased
14%
Vomiting
14%
Febrile neutropenia
13%
Myalgia
13%
Leukopenia
12%
Peripheral sensory neuropathy
12%
Back pain
11%
Hypertension
11%
Dysgeusia
11%
Insomnia
11%
Headache
11%
Arthralgia
11%
Asthenia
11%
Weight decreased
9%
Abdominal pain
9%
White blood cell count decreased
8%
Oropharyngeal pain
8%
Pain in extremity
8%
Thrombocytopenia
7%
Rash
7%
Dizziness
7%
Nail discolouration
6%
Dehydration
6%
Pain
6%
Dyspepsia
6%
Haemoptysis
6%
Paraesthesia
6%
Dysphonia
6%
Productive cough
6%
Hyperglycaemia
6%
Pneumonia
6%
Platelet count decreased
5%
Bone pain
1%
Chronic obstructive pulmonary disease
1%
Hyponatraemia
1%
Metastatic pain
1%
Lobar pneumonia
1%
Pleural effusion
1%
Pneumothorax
1%
Pulmonary embolism
1%
Pulmonary haemorrhage
1%
Syncope
1%
Confusional state
1%
Death
1%
Atrial fibrillation
1%
General physical health deterioration
1%
Renal failure acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ramucirumab and Docetaxel
Placebo and Docetaxel
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (ramucirumab, carboplatin, paclitaxel)Experimental Treatment3 Interventions
Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.
Group II: Arm B (carboplatin, paclitaxel)Active Control2 Interventions
Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Ramucirumab
2017
Completed Phase 3
~5050
Find a Location
Who is running the clinical trial?
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,104 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,745 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,601 Total Patients Enrolled
10 Trials studying Thymic Carcinoma
999 Patients Enrolled for Thymic Carcinoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any disqualifying conditions.My liver disease is severe (Child-Pugh B or worse).I have liver cirrhosis and a history of brain issues due to it.My thymic carcinoma cannot be removed by surgery and has spread.I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.I haven't had a heart attack, stroke, or similar event in the last 6 months.My blood pressure has been under control with medication.My cancer can be seen on scans taken within the last 28 days.I can take care of myself and am up and about more than 50% of my waking hours.I had chemotherapy for thymic carcinoma that ended 6 or more months ago.I have significant fluid buildup in my abdomen due to liver cirrhosis needing medication or drainage.I am not pregnant or nursing and will use effective birth control during and after the study.I haven't coughed up blood or have a tumor invading major blood vessels.I've had a brain scan in the last 42 days and either have no brain metastases or they've been treated and stable for 2 weeks without needing steroids.I cannot have surgery to remove my cancer.I cannot undergo radiation therapy aimed at curing my condition; however, I've had palliative radiation therapy over a week ago and have recovered from its side effects.I am not on regular blood thinning medication, except for possibly low-dose aspirin.I haven't had serious blood clots in the last 84 days.I switched from warfarin to low molecular weight heparin and my blood clotting levels have been stable for 14 days.I have not received any systemic anti-cancer treatments for my advanced thymic carcinoma.My kidney function, measured by creatinine levels, is within the required range.My recent urine tests show low protein levels.I have not had any serious gut issues or risks for them in the last 6 months.My cancer is confirmed as thymic carcinoma through tests.I haven't had severe GI bleeding in the last 84 days.I haven't had any serious wounds, ulcers, or broken bones in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (ramucirumab, carboplatin, paclitaxel)
- Group 2: Arm B (carboplatin, paclitaxel)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Thymic Carcinoma Patient Testimony for trial: Trial Name: NCT03694002 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions is Ramucirumab typically prescribed to treat?
"Ramucirumab is the treatment of choice for advanced endometrial cancer, but can also prove effective against melanoma metastasis, lymphoma non-Hodgkin's, and other neoplasms."
Answered by AI
What level of risk do patients encounter when taking Ramucirumab?
"The risk associated with Ramucirumab has been estimated at a 2 due to the presence of clinical data that vouch for its safety, though efficacy is yet to be confirmed."
Answered by AI
How many individuals have agreed to participate in this trial thus far?
"Affirmative. Information on clinicaltrials.gov demonstrates that this research project, which was published on August 9th 2018, is actively recruiting patients. Approximately 66 subjects must be enrolled from across 100 distinct locations."
Answered by AI
Are there still opportunities to volunteer for this research endeavor?
"Affirmative, according to clinicaltrials.gov this study is petitioning for participants which was first advertised on August 9th 2018 and updated lastly on January 6th 2022. The trial demands the recruitment of 66 individuals from 100 distinct sites."
Answered by AI
How many healthcare facilities in the state are conducting this clinical experiment?
"Participants of this clinical trial can be recruited from City of Hope South Pasadena in Southern California, Southwest Oncology PC located in Durango, Idaho, and the City of Hope West Covina situated in Alaska. Additionally, there are 100 other locations across the nation."
Answered by AI
Have there been any previous inquiries into Ramucirumab's efficacy?
"At the moment, 1202 clinical trials are in progress to investigate Ramucirumab with 336 of those at Phase 3. Shanghai is a major hub for research into this medication; however, there are 68186 medical institutions conducting various experiments across the world."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
Fox Chase Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I've done chemo, had surgery and radiation, but my cancer has returned. I am currently take 10mg of Everolimus daily, but would like to know if there are other treatments.
PatientReceived 1 prior treatment
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